Menveo (Intramuscular)

Meningococcal vaccine is a medicine that helps your body defend against infections caused by specific groups of meningococcal bacteria (A, B, C, W, and Y). It works by prompting your body to create its own antibodies to protect against the disease.

Meningococcal infections can lead to serious illnesses, such as meningococcal meningitis, which affects the brain, and meningococcemia, which affects the blood. These illnesses are more common in young children and in people with certain health conditions that make them more at risk for meningococcal infections or more likely to have severe complications from such infections.

Getting vaccinated against meningococcal disease is advised for individuals who are at risk of contracting the disease because:

• They have specific health conditions that increase their risk of a meningococcal infection or their chances of experiencing serious complications from a meningococcal infection.
• They are living in, working in, or visiting areas where there is a high chance of getting meningococcal disease.

This vaccine is recommended for people aged 10 to 25 years.

This vaccine should only be given by your doctor or under their supervision.

Be sure to tell your doctor about any side effects that happen after you get this vaccine.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and need immediate medical help. Contact your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after getting the vaccine.

Fainting may happen after you receive this vaccine. Your doctor might want you to be watched after you get the injection to prevent and manage fainting.

This vaccine may not protect everyone who receives it. It will not treat symptoms of meningococcal infection if you already have the disease.

In deciding to use a vaccine, you and your doctor need to weigh the risks against the benefits. For this vaccine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on how the Penbraya™ vaccine affects children younger than 10 years old. Safety and effectiveness have not been established for this age group.

Geriatric

Appropriate studies have not been done on how the Penbraya™ vaccine affects older adults. Safety and effectiveness have not been established for geriatric patients.

Breast Feeding

Studies suggest that this medication poses minimal risk to infants when used during breastfeeding.

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In some cases, two different medicines may be used together even if an interaction could occur. In these situations, your doctor may need to change the dose, or other precautions may be necessary. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when receiving this vaccine. The following interactions are highlighted due to their potential significance, but this list may not include all possible interactions.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Elivaldogene Autotemcel
• Measles Virus Vaccine, Live
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how your medicine interacts with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this vaccine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Immune system problems—This condition may reduce the effectiveness of the vaccine.

• Nerve problem (e.g., Guillain-Barré syndrome), history of—Use with caution. This may worsen the condition.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Incidence not known

• Chest tightness
• cough
• difficulty swallowing
• dizziness
• fainting
• fast heartbeat
• hives, itching, skin rash
• inability to move arms and legs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sudden numbness and weakness in the arms and legs
• trouble breathing
• unusual tiredness or weakness

Some side effects may happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to suggest ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• chills
• diarrhea
• fever
• headache
• joint pain
• muscle pain
• vomiting

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Bexsero
• Menactra
• MenQuadfi
• Menveo
• Trumenba

Available Dosage Forms:

• Suspension
• Kit
• Solution

Therapeutic Class: Vaccine

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into one of your muscles.

This vaccine is given in 2 doses at least 6 months apart.